Senior Associate, Regulatory Submissions & Registration (Biologics)

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart(R).

About the role

We are seeking a Regulatory Affairs Sr. Associate, with strong experience in dossier management, registration applications, and interactions with LATAM Health Authorities.

In this role, you will provide comprehensive regulatory support to the Director, Regulatory Affairs & Quality Assurance, with a focus on COFEPRIS interactions and product lifecycle management.

This position offers the opportunity to drive regulatory strategy and execution for product programs in the LATAM region. You will work independently on assigned deliverables while collaborating closely with global and regional

partners to ensure timely, compliant submissions and approvals.

Key Responsibilities

Regulatory Strategy & Planning

• Support the Director, Regulatory Affairs & Quality Assurance in the execution of regulatory strategies and priorities for product lifecycle

• Perform initial regulatory impact assessments for proposed global changes and provide recommendations on submission requirements, sequencing, dependencies, documentation needs, and anticipated timelines

• Identify and assess regulatory risks, issues, dependencies, and potential delays for assigned activities, and escalate them to the Director with proposed mitigation actions

• Monitor regulatory requirements, COFEPRIS criteria, procedural updates, and emerging practices; provide concise regulatory intelligence and impact assessments

Submissions & Authority Management

• Demonstrate hands-on experience supporting regulatory procedures before COFEPRIS, including preparation and follow-up submissions, responses to queries, commitments, and post-approval activities

• Coordinate labeling and artwork regulatory activities, including review of local prescribing information and packaging components, alignment with approved conditions, and implementation of safety-related updates

• Maintain an integrated regulatory portfolio view, including registrations, submissions, approvals, commitments, renewals, post-approval changes, authority requests, key dependencies, and upcoming milestones

• Maintain accurate regulatory plans, submission schedules, trackers, and status reports; provide clear operational updates to the Director and relevant stakeholders

• Own assigned regulatory activities end-to-end, proactively driving inputs, timelines, document readiness, follow-up, and closure

CMC & Post-Approval Changes

• Coordinate regulatory assessments and execution of CMC and manufacturing-related changes, including manufacturing sites, specifications, processes, analytical methods, packaging, and other post-approval changes

• Collaborate closely with Global Regulatory CMC, Quality, and Supply Chain teams to ensure alignment and timely execution

Documentation & Compliance

• Ensure regulatory records, submissions, approvals, correspondence, and commitments are appropriately documented and maintained in applicable Moderna regulatory systems and repositories

• Support the Director in the execution and follow-up of local Quality activities, priorities, and compliance requirements

• Support the management, documentation, and follow-up of quality events, including deviations, CAPAs, change controls, complaints, and other quality-related actions

• Support inspection and audit readiness activities, including preparation and organization of documentation, tracking of requests and observations, and follow-up of agreed actions

Cross-Functional Collaboration

• Coordinate with Global Regulatory, Regional Regulatory, Medical, Pharmacovigilance, Supply Chain, Quality, Commercial, and other cross-functional partners to obtain inputs and maintain delivery timelines

• Escalate strategic decisions, material risks, and authority-sensitive matters to the Director as appropriate

Required Qualifications

• BA/BS degree in a scientific, engineering, or healthcare discipline

• 5+ years of experience in the pharmaceutical industry, preferably in LATAM countries

• 3+ years of experience in regulatory strategy or relevant training/experience

• Exceptional written and oral communication in English and Spanish

• Strong knowledge of current US and EU regulations

• Strong experience with CTD format and content of regulatory filings

• Knowledge and broad experience with regulatory procedures and legislation for drug development, product registration, line extension, and license maintenance

• Demonstrated strong organizational skills, including the ability to prioritize workload

• Experience in the preparation of regulatory submissions and supportive amendments or supplements

• Experience authoring regulatory documents

• Knowledge and understanding of applicable regulations

Preferred Qualifications

• Masters, PharmD, or PhD degree

• Experience in Infectious Diseases and Biologicals

• Experience working on products in development, specifically relating to clinical and pre-clinical regulatory aspects

• Experience with regulatory procedures and legislation from both US and EU markets

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Parexel is a leading clinical research organization (CRO) providing comprehensive drug development and commercialization services to the pharmaceutical and biotech industries. We partner with innovative companies to bring life-changing therapies to patients worldwide. This position is being filled through our recruitment partnership services.

Originally posted on Himalayas